Seth Zuckerman
Senior Director, Biostatistics
Seth Zuckerman has over 28 years of experience working in the pharmaceutical industry. In addition to functioning as a Statistician for 23 years, he has also worked in Clinical Data Management and Clinical Trial Management. Prior to joining Galectin, Seth was Senior Director of Biostatistics at Cytel Inc. for 13 years, where he led several international projects for numerous pharmaceutical and biotechnology companies. His areas of statistical expertise include adaptive designs, SSRE (sample size re-estimation), interim analyses, regulatory submissions, FDA advisory committee experience and randomization procedures. Seth possesses an in depth understanding of the clinical trial process, having worked in Phases I through IV for pharmaceutical, biotechnology and medical device products. His therapeutic area knowledge includes the following: Gastroenterology, Oncology, Cardiovascular, Psychiatry, Neurology and Immunology.
Seth completed his undergraduate studies at Gettysburg College (Gettysburg, PA) with a BS in Biology and Minors in Mathematics and Spanish. He earned his MS in Statistics from Temple University (Philadelphia, PA).
Seth currently resides in Villanova, PA with his wife Eileen, four children (Erik, Helena, Joseph and Aaron), two cats (Nana and Tiger-Lilly) and one dog (Navi). Outside of work, Seth is an outdoor enthusiast and enjoys mountain biking, road cycling, hiking and ice hockey.
Jeff Katstra
Head of CMC and Pharmaceutical Development
Jeff is currently the Head, CMC and Pharmaceutical Development at Galectin. Prior to Galectin, Jeff served as Head, Development at Syntis Bio, a late stage preclinical company developing a new class of therapies through novel formulations that target specific tissues. Prior to Syntis, Jeff was Sr Director of Formulation and Process Development at Lyndra Therapeutics developing long acting oral medicines. Before Lyndra, Jeff was a Director at Agios Pharmaceuticals in their CMC group and helped develop to approval a medicine for AML and cholangiocarcinoma (TIBSOVO®). Jeff spent about a decade at Vertex Pharmaceuticals developing to approval medicines for HCV (INCIVEK®) and CF (KALYDECO®, ORKAMBI®, SYMDEKO®). These were developed via QbD strategies and with advanced manufacturing techniques such as spray drying and continuous manufacturing. Preceding Vertex, Jeff helped start up and incubate Pulmatrix out of Harvard University. He also worked at AIR, a subsidiary of Alkermes, on pulmonary drug delivery systems. Jeff is a trained mechanical/biomedical engineer out of the University of Michigan (Go Blue!). Jeff lives in the suburbs of Boston with his son Jack.
Jessica Kopaczewski
Senior Director, Clinical Operations
Jessica Kopaczewski is an accomplished clinical operations professional with over 25 years diverse experience in the pharmaceutical research industry supporting global study operations, site management, and personnel management across Phase 1 to IV in a variety of therapeutic indications including liver-related diseases, oncology, and infectious diseases. Prior to joining Galectin Therapeutics, she collaborated with CymaBay Therapeutics to manage operational aspects for their global phase III Primary Biliary Cirrhosis study. Before CymaBay, she consulted with Intercept Pharmaceuticals where she was responsible for the clinical operations oversight of their global phase III fibrosis due to NASH study. Prior positions include CRA functional management at PRA Health Sciences where she held a Leadership role within the BRIDGE CRA On-Boarding Program as a certified Barnett International CRA Training Instructor and was a key contributor to the development of a centralized CRA Quality Assessment Visit Team. Jessica also has prior experience managing global clinical teams from site selection through data analysis, monitoring, and study coordination of both pharmaceutical company-sponsored as well as physician written research trials. She is named as a contributor to several abstracts and posters relating to the treatment of NASH Cirrhosis as well as publications in reputable medical journals relating to the treatment of HIV/AIDs. Jessica received her B.S. in Biochemistry and Molecular Biology from the University of Wisconsin-Eau Claire.